BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE TRACK SMART SYSTEM

    MDR report key: 1071509 · Received July 2, 2008

    Report

    Report Number
    1052693-2008-00045
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 19, 2008
    Report Date
    June 24, 2008
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AN END USER CALLED FOR ASSISTANCE CHECKING THE RESULTS AS DISPLAYED IN THE DEVICE. AFTER PHONE TROUBLE-SHOOTING, IT WAS DISCOVERED THAT THE DEVICE'S DISPLAY WAS NOT PROPERLY SHOWING THE DIGITS FOR THE TEST RESULTS. THE DEVICE WAS REPLACED AND THE DEFECTIVE ONE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUE TRACK SMART SYSTEM BGM (BLOOD GLUCOSE MONITOR) NBW HOME DIAGNOSTICS, INC. TRUE TRACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1